PONVN-PONVNCT07749079
Risk Factors for Postoperative Nausea and Vomiting After Nasal Surgery Under General Anesthesia
An observational study of PONV, run by Eye & ENT Hospital of Fudan University.
Trial summary
The goal of this observational study is to learn how often postoperative nausea and vomiting occur in adults undergoing nasal surgery under general anesthesia and to identify factors associated with these events. The study will also describe other postoperative complications and factors that may affect recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PONV
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥18 years) scheduled to undergo elective nasal surgery under general anesthesia at three tertiary hospitals in China. Consecutive eligible patients who provide written informed consent will be enrolled in this multicenter prospective observational cohort study to evaluate the incidence and risk factors for postoperative nausea and vomiting.
Who may be able to join
- Scheduled to undergo nasal surgery under general anesthesia
- Aged 18 years or older
- Willing and able to provide written informed consent
Who cannot join
- Unable to cooperate with study procedures or complete study assessments for any reason, including language barriers, cognitive impairment, or inability to complete the questionnaires
- Considered unsuitable for participation by the investigator
About this study
Official title: Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Nasal Surgery Under General Anesthesia: A Multicenter Prospective Observational Cohort Study
The goal of this observational study is to learn how often postoperative nausea and vomiting occur in adults undergoing nasal surgery under general anesthesia and to identify factors associated with these events. The study will also describe other postoperative complications and factors that may affect recovery.
The main questions it aims to answer are:
Read more
- How many participants experience nausea, retching, or vomiting within 24 hours after surgery?
- Which patient characteristics, anesthesia-related factors, surgical factors, and perioperative medications are associated with postoperative nausea and vomiting?
- What other postoperative complications and nasal-related symptoms occur after surgery?
Approximately 1,000 adults undergoing nasal surgery under general anesthesia at three hospitals in China will be enrolled. This is an observational study, and participation will not change the anesthesia, surgery, medications, or other medical care selected by the treating clinical team.
Participants will:
- Complete assessments before surgery about their medical history, previous nausea or vomiting, anxiety, sleep, and recovery status
- Receive routine anesthesia and surgical care
- Be assessed for nausea, retching, vomiting, pain, nasal discomfort, and other complications during the first 24 hours after surgery
- Complete follow-up assessments after surgery, including follow-up by telephone after discharge, for up to 6 months
The study will use information from participant questionnaires, medical records, anesthesia records, and postoperative follow-up assessments.
Read the detailed description
This multicenter, prospective observational cohort study will evaluate postoperative nausea and vomiting in adults undergoing nasal surgery under general anesthesia at three hospitals in China. The study is designed to characterize the occurrence, timing, and severity of postoperative nausea and vomiting and to examine associations with patient-related, anesthesia-related, surgical, and perioperative management factors.
No study-specific treatment or change to routine clinical care will be required. Decisions regarding anesthetic technique, airway management, analgesia, antiemetic prophylaxis, fluid administration, surgical management, and postoperative treatment will be made by the clinical team according to usual practice at each participating center.
Data will be collected prospectively from participant interviews and questionnaires, medical records, anesthesia information systems, case report forms, and postoperative follow-up assessments. Preoperative data will include demographic and clinical characteristics, previous postoperative or post-discharge nausea and vomiting, motion sickness history, comorbidities, medication history, smoking and alcohol history, anxiety and depression, sleep quality, fasting duration, and baseline recovery status.
Perioperative data will include the type and duration of surgery, anesthetic and analgesic medications, antiemetic use, airway management, intraoperative fluids, physiologic measurements, adverse events, surgical field conditions, blood loss, and nasal surgery-specific factors such as nasal packing and procedure-related characteristics.
After surgery, participants will be assessed for nausea, retching, vomiting, use and response to rescue antiemetics, pain, fatigue, sleep quality, respiratory events, and nasal-related discomfort. Postoperative nausea and vomiting will be evaluated during prespecified intervals within the first 24 hours after surgery. Additional follow-up will assess post-discharge nausea and vomiting, postoperative complications, pain, sleep, psychological status, and nasal symptoms through telephone or in-person assessments for up to 6 months.
The collected data will be used to estimate the incidence of postoperative nausea and vomiting and to explore independent risk factors using multivariable statistical models. The study will also establish a prospective perioperative database to support future risk-prediction research and optimization of perioperative care for patients undergoing nasal surgery.
- Conditions
- PONV
- Keywords
- Postoperative nausea and vomiting, PONV, Nasal surgery, General anesthesia, Risk factors, Prospective cohort study, Perioperative complications
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults Undergoing Nasal Surgery Under General Anesthesia | This prospective observational cohort includes adults aged 18 years or older undergoing nasal surgery under general anesthesia. No study-specific intervention will be administered. Anesthetic management, surgical care, prophylactic antiemetic therapy, analgesia, and postoperative treatment will be determined by routine clinical practice at each participating center. Perioperative patient, anesthesia, surgical, and medication-related factors will be recorded, and participants will be followed to assess postoperative nausea and vomiting and other postoperative complications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Nausea and Vomiting Within 24 Hours
The proportion of participants who experience any episode of nausea, retching, or vomiting during the first 24 hours after surgery. Postoperative nausea and vomiting will be assessed during the following intervals: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours after anesthesia induction. A participant will be considered to have postoperative nausea and vomiting if nausea, retching, or vomiting occurs at any time during the 24-hour observation period.
Measured: From the end of surgery through 24 hours after surgery
Secondary outcomes (13)
Incidence of Clinically Significant Postoperative Nausea and Vomiting
The proportion of participants with clinically significant postoperative nausea and vomiting, defined as a total score of 50 or greater on the Postoperative Nausea and Vomiting Intensity Scale at any assessment.
Measured: At 6 hours, 24 hours, and postoperative day 3
Incidence of Vomiting or Retching Within 24 Hours
The proportion of participants who experience at least one episode of vomiting or retching within 24 hours after surgery. Events reported by either the participant or healthcare personnel will be included.
Measured: From the end of surgery through 24 hours after surgery
Number of Vomiting or Retching Episodes Within 24 Hours
The total number of vomiting or retching episodes experienced by each participant during the first 24 hours after surgery. Multiple episodes occurring within 5 minutes will be counted as one event unless separated by a clearly defined symptom-free interval.
Measured: From the end of surgery through 24 hours after surgery
Use of Rescue Antiemetic Medication
The proportion of participants receiving rescue antiemetic medication after surgery. The medication name, dose, administration time, and clinical response will be recorded. Response will be categorized as complete resolution, improvement, or no response.
Measured: From the end of surgery through postoperative day 3
Severity of Postoperative Pain
Postoperative pain at rest and with movement will be assessed using an 11-point Numeric Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity. Use of rescue analgesic medication will also be recorded.
Measured: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30
Postoperative Nasal and Related Symptoms
The severity of nasal and related postoperative symptoms will be assessed using individual 6-point scales ranging from 0 to 5, with higher scores indicating more severe symptoms. Symptoms include nasal obstruction, nasal discharge or blood-stained discharge, difficulty breathing through the nose, nasal pain or swelling, headache, dizziness, periocular discomfort, tearing, ear fullness, ear pain, facial pain or pressure, sleep disturbance due to nasal symptoms, and reduced sense of smell or taste.
Measured: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30
Postoperative Fatigue at Discharge
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Higher and lower scores will be interpreted according to the validated scoring method of the instrument.
Measured: At hospital discharge, anticipated within 3 days after surgery
Postoperative Short-term Sleep Quality
Postoperative short-term sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire.
Measured: At 24 hours, postoperative day 3, and postoperative day 30
Postoperative Longer-term Sleep Quality
Postoperative longer-term sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Measured: At 24 hours, postoperative day 3, and postoperative day 30
Incidence of Postoperative Pulmonary Complications
The proportion of participants who develop one or more postoperative pulmonary complications. Pulmonary complications will be classified according to the European Perioperative Clinical Outcome definitions and may include respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis.
Measured: Through postoperative day 30
Incidence of respiratory adverse events
The proportion of participants experiencing respiratory adverse events.
Measured: Within 24 hours, through postoperative day 3, and through postoperative day 30
Incidence of airway rescue interventions
The proportion of participants experiencing airway rescue interventions.
Measured: Within 24 hours
Incidence of Other Postoperative Complications
The proportion of participants experiencing other clinically relevant perioperative complications.
Measured: Within 24 hours, through postoperative day 3, and through postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenxian Li, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749079
- Sponsor's protocol ID
- ENTPONV-2026152
- Acronym
- N-PONV
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared through the SDB platform (https://www.scidb.cn/en) under controlled access. Access will be granted to qualified researchers whose research proposals are scientifically and ethically appropriate and approved according to the SDB data access procedures. Data users may be required to sign a data use agreement before access is granted.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Nasal Surgery Under General Anesthesia: A Multicenter Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07749079
- Acronym / sponsor ID
- N-PONV / ENTPONV-2026152
- Conditions
- PONV
- Keywords
- Postoperative nausea and vomiting, PONV, Nasal surgery, General anesthesia, Risk factors, Prospective cohort study, Perioperative complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn how often postoperative nausea and vomiting occur in adults undergoing nasal surgery under general anesthesia and to identify factors associated with these events. The study will also describe other postoperative complications and factors that may affect recovery.
The main questions it aims to answer are:
- How many participants experience nausea, retching, or vomiting within 24 hours after surgery?
- Which patient characteristics, anesthesia-related factors, surgical factors, and perioperative medications are associated with postoperative nausea and vomiting?
- What other postoperative complications and nasal-related symptoms occur after surgery?
Approximately 1,000 adults undergoing nasal surgery under general anesthesia at three hospitals in China will be enrolled. This is an observational study, and participation will not change the anesthesia, surgery, medications, or other medical care selected by the treating clinical team.
Participants will:
- Complete assessments before surgery about their medical history, previous nausea or vomiting, anxiety, sleep, and recovery status
- Receive routine anesthesia and surgical care
- Be assessed for nausea, retching, vomiting, pain, nasal discomfort, and other complications during the first 24 hours after surgery
- Complete follow-up assessments after surgery, including follow-up by telephone after discharge, for up to 6 months
The study will use information from participant questionnaires, medical records, anesthesia records, and postoperative follow-up assessments.
Detailed description
This multicenter, prospective observational cohort study will evaluate postoperative nausea and vomiting in adults undergoing nasal surgery under general anesthesia at three hospitals in China. The study is designed to characterize the occurrence, timing, and severity of postoperative nausea and vomiting and to examine associations with patient-related, anesthesia-related, surgical, and perioperative management factors.
No study-specific treatment or change to routine clinical care will be required. Decisions regarding anesthetic technique, airway management, analgesia, antiemetic prophylaxis, fluid administration, surgical management, and postoperative treatment will be made by the clinical team according to usual practice at each participating center.
Data will be collected prospectively from participant interviews and questionnaires, medical records, anesthesia information systems, case report forms, and postoperative follow-up assessments. Preoperative data will include demographic and clinical characteristics, previous postoperative or post-discharge nausea and vomiting, motion sickness history, comorbidities, medication history, smoking and alcohol history, anxiety and depression, sleep quality, fasting duration, and baseline recovery status.
Perioperative data will include the type and duration of surgery, anesthetic and analgesic medications, antiemetic use, airway management, intraoperative fluids, physiologic measurements, adverse events, surgical field conditions, blood loss, and nasal surgery-specific factors such as nasal packing and procedure-related characteristics.
After surgery, participants will be assessed for nausea, retching, vomiting, use and response to rescue antiemetics, pain, fatigue, sleep quality, respiratory events, and nasal-related discomfort. Postoperative nausea and vomiting will be evaluated during prespecified intervals within the first 24 hours after surgery. Additional follow-up will assess post-discharge nausea and vomiting, postoperative complications, pain, sleep, psychological status, and nasal symptoms through telephone or in-person assessments for up to 6 months.
The collected data will be used to estimate the incidence of postoperative nausea and vomiting and to explore independent risk factors using multivariable statistical models. The study will also establish a prospective perioperative database to support future risk-prediction research and optimization of perioperative care for patients undergoing nasal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Undergoing Nasal Surgery Under General Anesthesia | – | –This prospective observational cohort includes adults aged 18 years or older undergoing nasal surgery under general anesthesia. No study-specific intervention will be administered. Anesthetic management, surgical care, prophylactic antiemetic therapy, analgesia, and postoperative treatment will be determined by routine clinical practice at each participating center. Perioperative patient, anesthesia, surgical, and medication-related factors will be recorded, and participants will be followed to assess postoperative nausea and vomiting and other postoperative complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years) scheduled to undergo elective nasal surgery under general anesthesia at three tertiary hospitals in China. Consecutive eligible patients who provide written informed consent will be enrolled in this multicenter prospective observational cohort study to evaluate the incidence and risk factors for postoperative nausea and vomiting.
Key inclusion criteria (3 listed)
- Scheduled to undergo nasal surgery under general anesthesia
- Aged 18 years or older
- Willing and able to provide written informed consent
Key exclusion criteria (2 listed)
- Unable to cooperate with study procedures or complete study assessments for any reason, including language barriers, cognitive impairment, or inability to complete the questionnaires
- Considered unsuitable for participation by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Nausea and Vomiting Within 24 Hours
Time frame: From the end of surgery through 24 hours after surgery
The proportion of participants who experience any episode of nausea, retching, or vomiting during the first 24 hours after surgery. Postoperative nausea and vomiting will be assessed during the following intervals: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours after anesthesia induction. A participant will be considered to have postoperative nausea and vomiting if nausea, retching, or vomiting occurs at any time during the 24-hour observation period.
13 secondary outcomes
Incidence of Clinically Significant Postoperative Nausea and Vomiting
Time frame: At 6 hours, 24 hours, and postoperative day 3
Incidence of Vomiting or Retching Within 24 Hours
Time frame: From the end of surgery through 24 hours after surgery
Number of Vomiting or Retching Episodes Within 24 Hours
Time frame: From the end of surgery through 24 hours after surgery
Use of Rescue Antiemetic Medication
Time frame: From the end of surgery through postoperative day 3
Severity of Postoperative Pain
Time frame: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30
Postoperative Nasal and Related Symptoms
Time frame: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30
Postoperative Fatigue at Discharge
Time frame: At hospital discharge, anticipated within 3 days after surgery
Postoperative Short-term Sleep Quality
Time frame: At 24 hours, postoperative day 3, and postoperative day 30
Postoperative Longer-term Sleep Quality
Time frame: At 24 hours, postoperative day 3, and postoperative day 30
Incidence of Postoperative Pulmonary Complications
Time frame: Through postoperative day 30
Incidence of respiratory adverse events
Time frame: Within 24 hours, through postoperative day 3, and through postoperative day 30
Incidence of airway rescue interventions
Time frame: Within 24 hours
Incidence of Other Postoperative Complications
Time frame: Within 24 hours, through postoperative day 3, and through postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared through the SDB platform (https://www.scidb.cn/en) under controlled access. Access will be granted to qualified researchers whose research proposals are scientifically and ethically appropriate and approved according to the SDB data access procedures. Data users may be required to sign a data use agreement before access is granted.
Related trials for PONV
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PONV, run by Eye & ENT Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Nausea and Vomiting Within 24 Hours (time frame: From the end of surgery through 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.